NCT02530931

Brief Summary

  • This prospective study aims to better characterize inner ear's perilymphatic structures with Magnetic Resonance Imaging using contrast media and delayed injection in patient's with Meniere's disease.
  • MR Perfusion Imaging will be assess in both cochlea as well
  • Primary auditory brain pathways will be evaluated through MR diffusion imaging

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2016

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 21, 2015

Completed
7 months until next milestone

Study Start

First participant enrolled

March 16, 2016

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

November 18, 2020

Status Verified

November 1, 2020

Enrollment Period

4.5 years

First QC Date

August 18, 2015

Last Update Submit

November 16, 2020

Conditions

Meniere's Disease

Outcome Measures

Primary Outcomes (1)

  • Gadolinium enhancement in inner ear structures as measured by MR T1 Weighted-Imaging dynamic measurement

    One MR scan (4 hours)

Study Arms (1)

patients with Meniere's disease

EXPERIMENTAL
Drug: Gadolinium

Interventions

GadoliniumDRUG

diffusion of gadolinium for a population with Meniere's disease in order to develop an imaging disease screening test

patients with Meniere's disease

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Major subjects of over 40 years (mean age of Meniere's disease 40 to 50 years)
  • Informed consent signed
  • Medical examination performed prior to participation in research
  • Patients with clinical criteria of Meniere's disease according to the classification of the American Association of Otology (ie the combination of a sensorineural hearing loss at low frequencies, recurrent vertigo and tinnitus and / or clogged ear sensation)
  • Recipient of a French social security scheme

You may not qualify if:

  • Patients minors
  • Patients on a legal protection regime type guardianship
  • Respiratory pathologies, cardiovascular, renal, diabetes
  • Claustrophobia
  • Contraindications to exposure to a magnetic field
  • Contraindications to injecting Dotarem ®

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GrenobleUniversityHospital

Grenoble, 38043, France

Location

MeSH Terms

Conditions

Meniere Disease

Interventions

Gadolinium

Condition Hierarchy (Ancestors)

Endolymphatic HydropsLabyrinth DiseasesEar DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Lanthanoid Series ElementsMetals, Rare EarthElementsInorganic ChemicalsMetals

Study Officials

  • Arnaud ATTYE, PH

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2015

First Posted

August 21, 2015

Study Start

March 16, 2016

Primary Completion

September 1, 2020

Study Completion

September 1, 2020

Last Updated

November 18, 2020

Record last verified: 2020-11

Locations

FR(1)